|From:||Alfred Del Grosso HFM-406, PQLS, DPQ, OVRR|
Hsiaoling Wang HFM-406, PQLS, DPQ, OVRR
|Subject:||Test Results for Residual Moisture, pH and Solubility for Three (3) Lots of Antithrombin alfa (Recombinant) (ATryn) from GTC Biotherapeutics Inc. (license #1794)|
Lots 06C03-61, 06C10-61, 06C31-61
|To:||Roman Drews HFM-392 LH, DH, OBRR and Pending License File STN 125284/0|
|Through:||William McCormick HFM-407, DPQ, OVRR|
Rajesh Gupta HFM-407 PQLS, DPQ, OVRR
Determination of residual moisture content was performed by CBER using Karl Fischer coulometric titration with methanol extraction of the lyophilized sample. The reported results are the averages of measurements performed on two separate vials submitted to our division. Test results are as follows:
GTC Biopharmaceuticals Inc. has specified a limit for residual moisture of -b(4)- for this product. CBER’s test results for these lots meet this specification.
Testing for pH and solubility were requested by Roman Drews, DH, OBRR. pH was performed as described in DPQ test method Doc. ID 000482, “pH Determination”. Solubility was evaluated after reconstitution with 10 ml of ASTM Type 1 reagent grade water. Evaluation for pH and solubility were performed on single vials of reconstituted product for each lot submitted.
The allowable range for pH in the license application submitted for this product is --b(4)---. Results obtained by CBER meet this specification.
Acceptance criterion for solubility is that dissolution time with slight swirling be not more than --b(4)---. The submitted samples of these lots were evaluated as meeting these criteria.